It is often necessary to aspirate a patient to remove fluids and/or particles. Suction can be applied to maintain a patient's airway, and it can also be used to remove fluids from a surgical site. The area to be suctioned may be easily accessible through a large orifice or it may be in a hard to reach deep recess. Various suction equipment is available to meet the particular demands of the different situations requiring patient aspiration.
Neonates present one situation in which patient aspiration is, in various degrees, a routine practice. Since neonates, almost immediately upon delivery, change from being dependent on placental oxygen delivered through the umbilical vein, to room air oxygen inspired into the lungs, their oropharynx and nasopharynx must be suctioned to ensure the patency of these passageways and to prevent inhalation of fluid and/or particles located therein. Nasal suctioning is of particular importance in neonates as they are known to be obligate nasal breathers. A long thin flexible catheter is often used for suctioning newborns because of the ability to go both short distances into the nares and mouth as well as going beyond the nasopharynx and oropharynx, into the esophagus and stomach, to remove swallowed secretions. The ability to suction the esophagus and stomach is important because secretions located therein may be regurgitated and subsequently inhaled into the trachea and lungs.
Although simple and useful, control of the flexible catheter is limited, especially when suctioning in small oral cavities. The flexible catheter often requires use of both hands: one to direct the distal end of the catheter tip, the other to manipulate the suction port at the proximal end. Even when one attempts to operate the flexible catheter with one hand, a second hand is necessary to gather the catheter, position it at an optimal length, stabilize the length of the catheter, control the suction port and maintain the integrity of the suction system's connection. Since in the context of patient aspiration a free hand is often required to perform other functions-- such as monitoring umbilical pulse rate, stabilizing and positioning the head, stabilizing the body, opening the jaw, handling equipment, drying the baby, and/or administering oxygen-- the use of a flexible catheter can impair the patient care effort.
Accordingly in larger patients and other instances where the cavity to be suctioned is sufficiently large, the flexible catheter is often replaced with a rigid catheter, which provides more control. One common example of a rigid catheter is the Yankauer. However, some of the benefits associated with the flexible catheter, such as nasopharyngeal suction and entrance into irregular spaces, a common demand during surgical procedures, are lost when using a rigid catheter.
It is apparent that, in many situations, use of both the rigid catheter and the flexible catheter is advantageous. Yet, using two catheters entails multiple, time-consuming steps, especially if only one suction source is used, including: connecting the first suction catheter, performing the first function, detaching the first suction catheter, attaching the second catheter, and performing the second function. In addition, this procedure disrupts the flow of the aspiration effort and requires use of hand resources which could be performing other vital functions. This problem occurs during resuscitation, as well as during routine procedures such as suctioning a patient on a ventilator or suctioning body cavities during surgical procedures.
It is therefore, a principle objective of the present invention to provide a single device which functions as both a flexible and a rigid catheter. In its most rudimentary form, a flexible catheter and a rigid catheter whose distal and proximal ends are open, are connected side by side. The flexible catheter is attachable to a source of negative pressure and can be used as an ordinary flexible suction device when so desired. If a rigid suction device is indicated, the flexible catheter is inserted through the proximal open end of the rigid catheter, thereby causing the flow of negative pressure to exit through the distill open end of the rigid catheter.
As stated above, aspiration is a routine part of the delivery of neonates. In addition to the amniotic fluid that has to be removed from the neonatal's oropharynx and nasopharynx approximately ten percent (10%) of all neonates present with meconium in their airway, as well. Since inhaling the particulate matter of meconium can lead to hypoxia, acidosis, and a chemical pneumonitis, which in turn may result in severe morbidity or death, the presence of meconium is considered an emergency and the meconium fluid is often removed from the oropharynx intrapartum, by the obstetrician, as the baby's head is delivered. The baby is immediately intubated and suctioned to retrieve any aspirated meconium prior to the first breath of the infant, which would draw the meconium down into the lungs.
The situation is very tense as a skilled provider must use many pieces of equipment to rapidly intubate and suction either a limp, blue, non-breathing baby or a more active thrashing baby, before its first breath. To intubate, the operator must secure the head and body of the baby, position the head properly, retrieve and open a laryngoscope, open the baby's mouth, maintain its patency, insert the laryngoscope, locate, position and visualize the vocal cords to properly introduce an endotracheal ("ET") tube, find and properly grasp an ET tube, maintain visual contact with the vocal cords while introducing the ET tube into the oropharynx, introduce the ET tube, stabilize the ET tube, remove the stylet from within the lumen of the ET tube, attach the aspirator to the ET tube and suction. If necessary, this procedure is repeated until the baby is properly intubated.
Moreover, when the meconium is located above the vocal cords in the hypopharanyx, obstructing the line of sight to the vocal cords, the resuscitation effort becomes more difficult and the possibility of inhaling the meconium increases. While the objective, to place an ET tube into the trachea and apply negative pressure to aspirate any meconium is straightforward, it can be difficult due to the many factors affecting its success. Since each second delays the initiation of breathing and prolongs the hypoxia of the infant and secondary acidosis, time is of the essence.
It will be readily apparent to anyone skilled in the art that these difficulties are not peculiar to neonatal delivery. For example, with slight differences, emergency medical personnel face similar problems both in the field and in the emergency room.
While it is recommended by the Neonatal Advanced Life Support ("NALS") guidelines that two people be in attendance at meconium deliveries, the presence of meconium often times remains unknown until the end of the delivery process or during a precipitous delivery in which the pediatric staff is called emergently and the process of intubation is performed by the first single person present who is qualified to intubate. Indeed, single-operator meconium intubation is not an uncommon occurrence. In this situation, the difficulties elaborated above are compounded by the fact that the single operator must engage both hands to manipulate the equipment transfer and operate the multiple devices. The operator must often break visual contact with the vocal cords, as well as release the laryngoscope. If the laryngoscope is released before the ET tube is securely inserted in the trachea, the entire intubation process must be repeated. The equipment commonly available, as well as the prior art disclosures in this field do not adequately provide an effective solution.
It is therefore a second principal objective of the present invention to provide a single device which incorporates nearly all the necessary equipment for ventilation, aspiration and instillation of fluids to reduce if not eliminate the various difficulties described above. Since the multiple pieces of equipment are replaced with a single device, fewer steps are required in the initial setup, the possible need for searching for lost or misplaced equipment, the anxiety and distraction associated with such searches, and the need to maintain the juxtaposition and orientation of additional equipment, as well as the potential for entropy and chaos is decreased.
This single device includes a first inlet port for suctioning particulate matter such as meconium and a second inlet port for suctioning through a flexible or rigid catheter. The first inlet port has an inner diameter such that an ET tube adapter can be inserted therein and is situated relative to the second inlet port for the flexible or rigid catheter such that insertion of the ET tube adaptor through the first inlet port occludes the second inlet port. Accordingly, the flow of negative pressure can be alternately directed through the first inlet port and the second inlet port.
In addition since some situations requiring aspiration also require ventilation or application of positive pressure, the present invention also provides a novel port design that permits simultaneous attachment of a positive pressure source without removal of the endotracheal tube, thereby saving time and minimizing equipment. In neonatal resuscitation, this device would allow both suctioning and ventilation through the same ET tube, or suctioning and instillation, as for example, when performing a lung lavage as has been tried experimentally with surfactant. This novel port has dimensions to accommodate standard ventilation connectors as well as easy occlusion by a finger as would normally be necessary for flow control.
Other objectives of the present invention include a single resuscitation device with numerous finger grips and appendages for a more secure hold, especially desirable while wearing gloves; use of mechanical suction rather than poorly regulated mouth suction; and a single aspiration ventilation and instillation device attached to a non-interfering standard ET tube. Another objective of the present invention relates to the devices described above and suction devices in general. The difficulties in aspirating patients as described above, are complicated by the dangling hoses which connect ventilation and aspiration attachable devices to sources of oxygen and negative pressure, respectively. These hoses interfere with the operation and transfer of the attachable device by obstructing the line of sight and by projecting back toward the operator of the device, inhibiting free movement. An improved connecting appendage is described with an open proximal end extending from the attachable device toward the distal end and lateral side of the device forming an oblique angle with the attachable device. Thus, the connecting hose is directed away from the device, minimizing interference with the operator.
In addition, the oblique angle formed between the connecting appendage and the attachable device functions as a hook so that the device can conveniently hang from a stretcher, tray or other nearby edge. This helps to prevent potential slippage onto the ground, caused by the weight of the connecting hose to the relative lightweight device and maintains the device within hygienic domains and the operators immediate field of use, providing easier access.
Several prior art devices in the field of aspiration and ventilation follow: U.S. Pat. Nos. 4,699,138 ("'138") and 4,787,894 ("'894") provide an ET tube which can be used to suction and intubate the oropharynx simultaneously. Several problems are associated with these devices. First, the presence of the stylet in the ET tube of the '138 device, and the rigid wire embedded between the walls of the '894 device obstructs the suction flow for large of meconium particulate. While, in the '138 device, it is possible to remove the stylet, it requires the use of a second hand, forcing a single operator to release the laryngoscope. As explained above, this prolongs the intubation process and wastes precious time. Second, there is no teaching and presumably the device is incapable of, nasopharynx suctioning. Third, since a single channel is used for suctioning, the device does not provide a means to differentiate between meconium removed from the trachea and meconium removed from the oropharynx. The origin of the meconium is an important consideration for deciding whether further suctioning is indicated prior to ventilation.
Other prior art devices are disclosed in U.S. Pat. Nos. 4,275,724 ("'724"), 4,915,691 ("'691") and 5,000,175 ("'175"). The differences as well as the advantages of the present invention over these prior art devices will become apparent as the invention is described below.